A Study of NT-175 in Adult Participants With Advanced Malignancies That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation
Start Date
7/12/2023
Completion Date
7/31/2029
Summary
Phase I Study of NT-175, an autologous T cell therapy product genetically engineered to express an HLA-A\*02:01-restricted T cell receptor (TCR), targeting TP53 R175H mutant malignancies
Detailed Description
This is a Phase 1, open-label, multicentre platform study to evaluate the safety and preliminary antitumour activity of NT-175 in HLA-A\*02:01 participants with advanced malignancies that are positive for the TP53 R175H mutation. Dose Escalation will investigate escalating doses of NT-175 in adult subjects with eligible histologies and will evaluate the safety and MTD and/or RDE/RP2D. Cohort expansion will further evaluate the safety and preliminary anti-tumour activity at or below the MTD in disease specific histologies and determine the RP2D. Dose Expansion will further evaluate the preliminary anti-tumour activity and safety of NT-175 at the RP2D in disease specific settings.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
NT-175
Conditions
Locations
Research Site
Gilbert, Arizona 85234
United States
Research Site
Duarte, California 91010
United States
Research Site
Newport Beach, California 92663
United States
Research Site
Santa Monica, California 90404
United States
Research Site
Jacksonville, Florida 32224
United States
Research Site
Miami, Florida 33136
United States
Research Site
Tampa, Florida 33612
United States
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Boston, Massachusetts 02115
United States
Research Site
New Brunswick, New Jersey 08901
United States
Research Site
New York, New York 10065
United States
Research Site
Charlotte, North Carolina 28204
United States
Research Site
Winston-Salem, North Carolina 27103
United States
Research Site
Portland, Oregon 97213
United States
Research Site
Pittsburgh, Pennsylvania 15232
United States
Research Site
Nashville, Tennessee 37203
United States
Research Site
Houston, Texas 77030
United States
Research Site
Round Rock, Texas 78665
United States
Research Site
Milwaukee, Wisconsin 53226
United States